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A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp

Study acronym: AKtive
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 450 to confirmed 447 · Study sites: 47 to 49 · Primary and study completion dates: Mar 2027 to Jul 2027v7 Show 3 more changesShow less
    • Enrollment target: estimated 450 to confirmed 447
    • Study sites: 47 to 49
    • Primary and study completion dates: Mar 2027 to Jul 2027
  2. Minor Re-verified, no change to tracked fieldsv6
  3. Minor Enrollment target: 540 to 450v5
  4. Notable Primary and study completion dates: Mar 2026 to Mar 2027 Study sites: 46 to 47v4 Show 1 more changeShow less
    • Study sites: 46 to 47
  5. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 41 to 46 · Start date changed from estimate of Aug 2022 to Oct 24, 2022v3 Show 2 more changesShow less
    • Study sites: 41 to 46
    • Start date changed from estimate of Aug 2022 to Oct 24, 2022
  6. Minor Re-verified, no change to tracked fieldsv2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of the study is to evaluate the incidence of biopsy confirmed invasive squamous cell carcinoma (SCC) in the selected treatment field (TF) after administration of topical tirbanibulin 10 milligram (mg)/gram (g) ointment or diclofenac sodium 3 percent (%) gel over the 3-year study period.
Trial Details
NCT Number NCT05387525
Lead Sponsor Almirall, S.A.
Conditions Keratosis, Actinic
Enrollment 447 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov